Healthy Clinical Trial
Official title:
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.
Primary objectives:
1. Establish a human challenge model of S. sonnei 53G infection using a lyophilized
formulation of the challenge strain.
2. Identify a dose of lyophilized S. sonnei 53G that induces the primary outcome in
approximately 60% of subjects with no adverse safety concerns.
Secondary objectives:
1. Estimate quantitative shedding and basic immunogenicity of the challenge strain.
2. Collect and archive blood and fecal samples for systems biology, microbiome, and other
omics-based work to be conducted under a separate research protocol in future studies.
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